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Clinical Trials in China / NCT05896800
Recruiting Not applicable

A Clinical Study of Inhaled Nitric Oxide in Moderate-to-Severe Chronic Obstructive Pulmonary Disease

NCT05896800 · tracked via the Priya Life Science China tracker
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Phase
Not applicable
Started
2023-06-01
Last updated
2025-06-18

Condition(s) studied

Chronic Obstructive Pulmonary Disease

Investigational drug(s) / intervention(s)

Inhaled nitric oxide (NO)air

Inhaled nitric oxide (NO): The Nitric Oxide Generation and Delivery System is used to deliver nitric oxide for inhalation therapy into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath.

air: use air(21%O2)as the placebo of inhaled treatment

Study summary

The purpose of this study is to evaluate the influence of exercise capacity and safety of iNO at doses of 10 ppm or 40 ppm for 2 hours per day after continuous treatment for one week, which is of great significance for finding safe and effective methods for treating COPD.

Eligibility

Sex
ALL
Min age
40 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥ 40 years, ≤ 75 years; 2. Previous smoking history ≥ 10 pack-years, and had stopped smoking for one month before study entry; 3. Met the diagnosis criteria of moderate and severe COPD: a post-bronchodilator FEV1/FVC \< 0.7, and 30%\< FEV1 \< 80% predicted; 4. Signed informed consent and performed all the study mandated procedures. Exclusion Criteria: 1. Pregnant or lactating women; 2. Current or recent month user of nicotine-like substances (including nicotine patches, etc.); 3. A diagnosis of asthma or other non-COPD respiratory disease, in the opinion of the Investigator; 4. Lack of patency of nares upon physical examination; 5. Experienced during the last month an exacerbation requiring start of or increase in systemic oral corticosteroid therapy; 6. Left ventricular systolic dysfunction: left ventricular ejection fraction (LVEF) \< 50%; 7. Clinically significant valvular heart disease, including aortic valvular disease (moderate or severe aortic stenosis or regurgitation) and/or mitral valve disease (moderate or severe mitral stenosis or regurgitation), or status post mitral valve replacement; 8. Use within 30 days of screening or current use of approved pulmonary hypertension medications such as sildenafil, bosentan or prostacyclines; 9. Use of investigational drugs or devices within 30 days prior to enrollment into the study; 10. Any underlying medical or psychiatric condition that, in the opinion of the Investigator, makes the subject an unsuitable candidate for the study.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital with Nanjing Medical University Nanjing Jiangsu Recruiting

More The First Affiliated Hospital with Nanjing Medical University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05896800 on ClinicalTrials.gov ↗ ← All trials in China